|- candidate number||2577|
|- NTR Number||NTR969|
|- ISRCTN||wordt niet aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mei-2007|
|- Secondary IDs|| |
|- Public Title||Observational study|
End organ damage in patients with hypertenion: a magnetic resonance imaging approach.
|- Scientific Title||N/A|
|- hypothesis||Hypertension causes subclinical and clinical damage in end organs. The exact manifestations of end organ damage in hypertension itself are unknown. The hypothesis is that differences in the cardiovascular risk profile in hypertensive patients are associated with specific symptomatic and asymptomatic manifestations of microvascular disease. |
|- Healt Condition(s) or Problem(s) studied||Hypertension, 3T MRI, Organ failure|
|- Inclusion criteria||1. Age > 18 years;|
2. Patients with proven hypertension (i.e. blood pressure of > 140/90mmHg on repeated examination according to (8)).
|- Exclusion criteria||1. Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD, vascular clips, atrial fibrillation or sustained ventricular tachycardia pregnancy and claustrophobia).
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||17-okt-2007|
|- planned closingdate||1-feb-2010|
|- Target number of participants||200|
|- Interventions||MR assesment heart, aorta and brain.|
|- Primary outcome||Exact manifestations of organ damage in heart, aorta and brain in patients with hypertension.|
|- Secondary outcome||Adjusted risk profiles on cardiovascular diseases.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Mw. Drs. A. Brandts|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Drs. A. Brandts|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC), Dutch insurance companies|
|- Brief summary||Background:|
Hypertension causes subclinical and clinical damage in end organs. The exact manifestations of end organ damage in hypertension itself are unknown. Recently, MRI has been established as an accurate, non-invasive tool for assessment of organ damage in the heart, the aorta and the brain. The aim of our study is assess subclinical and clinical manifestations of end organ damage in the heart, the aorta and the brain in patients with hypertension by 3Tesla MRI.
We will perform an observational study in patients with hypertension. Patients are derived from the “Leiden Hypertensive clinic” at the Leiden University Medical Centre (LUMC). In the next two years, we will include approximately 200 patients. Also, 25 healthy volunteers will be included as control subject. Besides routine hypertension screening, patients will undergo MR assessment of the heart, the aorta and the brain.
MRI will be an accurate, non-invasive tool to further delineate the phenotype of end organ damage in patients with hypertension.
|- Main changes (audit trail)|
|- RECORD||11-mei-2007 - 12-nov-2008|